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Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases (Lili smart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295110
Recruitment Status : Unknown
Verified September 2017 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : September 27, 2017
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
Lili smart
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

Alzheimer's disease and related diseases (ADRD) are a major public health issue. In France, nearly 900,000 people have ADRD, which represents about 70% of dementia cases, and the expected prevalence for 2020 is 1.2 million.

Patients with ADRD have cognitive, behavioral and functional impairments that lead to progressive impairment of quality of life and autonomy. Maintaining them at home depends predominantly on their caregivers, mainly family, spouse or child. By definition, the caregiver is "the person who provides partial or total support to an elderly dependent person or a person with a disability in the vicinity of the victim for the activities of daily life".

The investment of caregivers is therefore both human and financial, representing a greater or lesser burden. This burden can significantly affect their quality of life. Indeed, studies have shown that caregivers suffer from depletion, anxiety, depression and sleep disorders resulting in a deterioration of their health, leading them to greater care consumption. They would be more prone to cardiovascular diseases and cancer.

A review of the literature from 2009 examined 66 studies evaluating the contribution of various technologies targeting demented patients and their caregivers. Of these, only 10 dealt with independence at home and the well-being of the patient and his / her caregiver. The main limitations of these studies are the small samples (ranging from 1 to 6 patients), the degree of cognitive degradation (mainly moderately severe) and the lack of standardized assessment.

Although new technologies promise powerful home-based solutions, studies evaluating their efficacy for patients with ADRD and their caregivers remain scarce and fragile at the level of evidence due to methodological biases.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: Functionalities of the Lili Smart Solution activated Other: Functionalities of the Lili Smart Solution non activated Not Applicable

Detailed Description:

Description of the intervention: Lili Smart solution consists of an application for caregivers (web / mobile), a GSM watch worn by the patient, smart sensors placed at different locations of the patient's home and a support service 24 / 24 and 7/7.

Objectives: The main objective is to evaluate the impact of the Lili Smart solution on the burden felt by caregivers of patients with ADRD at 3 months and at 6 months of follow-up.

The secondary objectives are to evaluate the impact of the Lili Smart solution at 3 months and 6 months of follow-up on:

  • The anxiety of the caregiver of the patient with ADRD;
  • Depression of the caregiver of the patient with ADRD;
  • The quality of life of the caregiver of the patient with ADRD;
  • The quality of life of the patient with ADRD,
  • The level of functional autonomy of the patient with ADRD.
  • The risks associated with the functional decline (falls, run aways) of the patient with ADRD.

In addition to the social impact measurement, the study aims to demonstrate the medico-economic impact of Lili smart solution as follow:

  • The direct and indirect medical costs of the patient and the caregiver.

Patient and caregiver adherence to the Lili Smart solution will also be assessed as a secondary objective.

Methodology : This study is an interventional research on the human person meeting the definition 1 ° of article L1121-1 of the CSP and not relating to the products mentioned in article L. 5311-1 It is a randomized, controlled, single-blind, parallel-group, interventional, randomized, controlled trial in N = 60 patients and their primary caregiver with an observational phase (inactive device), and one interventional phase (activated device).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lili Smart Study - Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Functionalities of the Lili Smart Solution activated
Lili Smart solution consists of an application for caregivers (web / mobile), a GSM watch worn by the patient, smart sensors placed at different locations of the patient's home and a support service 24 / 24 and 7/7.
 Other: Functionalities of the Lili Smart Solution activated
Non-medical connected device (Lili Smart solution) activated : application for caregivers (web / mobile), GSM watch worn by the patient, smart sensors placed at different locations of the patient's home and a support service 24 /24 and 7/7.
Other Name: Non-medical connected device (Lili Smart solution) with active functionalities
Functionalities of the Lili Smart Solution non activated
Lili Smart watch worn by the participants and sensors placed at home with their functionalities inactivated. Absence of the web / mobile application.
 Other: Functionalities of the Lili Smart Solution non activated
Non-medical connected device (Lili Smart solution) with inactive functionalities : watch worn by the participants and sensors placed at home with their functionalities inactivated. Absence of the web / mobile application.
Other Name: Non-medical connected device (Lili Smart solution) with inactive functionalities


Outcome Measures
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Primary Outcome Measures :
  1. Caregiver's burden evolution [ Time Frame: 6 months after randomization ]
    Natural caregiver's burden evolution after 6 months of follow-up. Natural caregiver's burden evolution after 6 months of follow-up. Assessement with the Zarit scale


Secondary Outcome Measures :
  1. Evolution of the caregiver's anxiety level [ Time Frame: 3 months and 6 months after randomization ]
    Evolution of the caregiver's anxiety level estimated with repeated measures with the Spielberger's State-Trait Anxiety Inventory (STAI Y-A / Y-B).

  2. Evolution of the caregiver's depressive symptomatology [ Time Frame: 3 months and 6 months after randomization ]
    Evolution of the caregiver's depressive symptomatology estimated with repeated measures of the Beck Depression Inventory (BDI)

  3. Evolution of the caregiver's quality of life [ Time Frame: 3 months and 6 months after randomization ]
    Evolution of the caregiver's quality of life estimated with repeated measures of the Quality of Life in Alzheilmer's Disease scale, caregiver version

  4. Evolution of the patient's quality of life [ Time Frame: 3 months and 6 months after randomization ]
    Evolution of patient's quality of life estimated with repeated measures of the Quality of Life in Alzheilmer's Disease scale, patient version

  5. Evolution of the patient's independence [ Time Frame: 3 months and 6 months after randomization ]
    Evolution of the patient's independence with repeated measures of the Instrumental Activities of Daily Life (IADL-E, 9 items).

  6. Evolution of the caregiver's quality of life [ Time Frame: 3 months and 6 months after randomization ]
    Evolution of the caregiver's quality of life estimated with repeated measures of the Quality of Life with EQ-5D questionnaire (EuroQol Five Dimensions questionnaire).

  7. Evolution of the patient's quality of life [ Time Frame: 3 months and 6 months after randomization ]
    Evolution of patient's quality of life estimated with repeated measures of the Quality of Life with EQ-5D questionnaire (EuroQol Five Dimensions questionnaire).

  8. Number of falls [ Time Frame: 1 months, 3 months and 6 months after randomization ]
    Number of times the patient has fallen after 1 month, 3 months and 6 months.

  9. Number of run aways [ Time Frame: 1 months, 3 months and 6 months after randomization ]
    Number of times the patient has ran away after 1 month, 3 months and 6 months.

  10. Number of drugs prescribed to the caregiver and the patient [ Time Frame: at inclusion and at 6 months ]
    Evolution of the number of drugs prescribed to the caregiver and the patient at inclusion and after 6 months of follow-up.

  11. Indirect medical costs and direct non-medical costs [ Time Frame: 6 months ]
    Data for indirect medical costs and direct non-medical costs will be collected with the RUD LITE questionnaire and the Lyon CMRR's MEMORA database

  12. Evaluation of the caregiver's adherence to the Lili Smart solution [ Time Frame: 7 months ]
    Evaluation of the caregiver's adherence to the Lili Smart solution after 7 months of follow-up (1 month of observation phase then 6 months of intervention) estimated through data collected in Lili Smart databases (number of connections to the application).

  13. Evaluation of patient's adherence to the Lili Smart solution [ Time Frame: 7 months ]
    Evaluation of the patient's adherence to the Lili Smart solution after 7 months of follow-up (1 month of observation phase then 6 months of intervention) estimated through data collected in Lili Smart databases (number of hours when the watch is worn).

  14. Caregiver's burden evolution [ Time Frame: 3 months after randomization ]
    Natural caregiver's burden evolution after 3 months of follow-up. Assessement with the Zarit scale


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Caregiver inclusion's criteria :

  • Natural caregiver helping the patient at least 6h / week for activities of daily living (if more than one caregiver, only one "referent" caregiver will be involved);
  • Can be the caregiver of only one patient of the study.
  • Having the ability to follow the study at the discretion of the investigator;
  • Having agreed to participate in the study;
  • Affiliated to a social security scheme;

Patient Inclusion Criteria:

  • Diagnosis of Alzheimer's disease or related disease;
  • Living at home
  • Age ≥ 50 years
  • Mini Mental State Examination (MMSE): 16-24 (included) (light to moderate);
  • Affiliated to a social security scheme;
  • Having agreed to participate in the study;
  • Having the physical and psychic abilities to follow the study according to the appreciation of the investigator.

Exclusion Criteria:

Patients exclusion's criteria:

  • Known psychiatric disorders
  • Disabling motor and / or sensory impairment
  • Patient under guardianship
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295110


Contacts
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Contact: Deborah Viricel 4 72 43 25 01 ext +33 deborah.viricel@chu-lyon.fr
Contact: Romain Bachelet 4 72 43 22 25 ext +33 romain.bachelet@chu-lyon.fr

Locations
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France
Hopital des Charpennes Recruiting
Villeurbanne, France, 69100
Contact: Pierre Krolak Salmon, Pr         
Sponsors and Collaborators
Hospices Civils de Lyon
Lili smart
Investigators
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Principal Investigator: Pierre Krolak-Salmon, MD Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03295110    
Other Study ID Numbers: 69HCL16_0706
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Alzheimer's disease and Related Disorders (ADRD)
natural caregiver
non-medical connected device
caregiver's burden
anxiety
 costs
quality of life
depressive symptoms
independence
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Pharmaceutical Solutions